Sun Pharma Recalls Levetiracetam Extended Release Tablets for Dissolution Failure
Sun Pharma Global Fze is recalling 3,263 bottles of Levetiracetam extended release tablets because they failed to meet dissolution specifications at the 6-month time point.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) without reported injuries or illnesses, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Sun Pharma Global Fze is voluntarily recalling 3,263 bottles of Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only. The product was manufactured by Sun Pharmaceutical Ind. Ltd in Gujarat, India, and is identified by NDC Number 47335-576-86, Lot # JKN0249A, with an expiration date of 02/2016.
The recall was initiated because the affected tablets failed to meet dissolution specifications at the 6-month time point. Dissolution testing ensures that the medication releases the active ingredient at the intended rate; failure to meet these specifications may affect the drug's performance.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.
The recalled product
- Product
- Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86
- Manufacturer
- Sun Pharma Global Fze
- Category
- Drug — Anticonvulsant
- Hazard
- Affected units
- 3,263
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: JKN0249A Exp 02/2016
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Sun Pharma Global Fze
See all →- ModerateSun Pharma Recalls Alendronate Sodium Tablets Due to Impurity Levels
FDA (Drugs) · 2016-03-09
- LowSun Pharma Recalls Bupropion Hydrochloride Tablets for Dissolution Failure
FDA (Drugs) · 2015-08-26
- ModerateSun Pharma Recalls Ketorolac Ophthalmic Solution Due to Particulate Matter
FDA (Drugs) · 2015-03-04
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateAjanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
Similar recalls
- ModerateSun Pharma Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2014-11-12
- ModerateSun Pharmaceutical Recalls BuPROPion Hydrochloride Tablets for Dissolution Failures
FDA (Drugs) · 2017-02-01
- LowSun Pharmaceutical Recalls Bupropion Hydrochloride Tablets for Dissolution Failure
FDA (Drugs) · 2016-07-27
- LowSun Pharma Recalls Bupropion Hydrochloride Tablets for Dissolution Failure
FDA (Drugs) · 2015-08-26
- HighBupropion Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2023-05-31
- ModerateSun Pharmaceutical Bupropion Extended-Release Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2023-10-25